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Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Who can join

Ages 18 to 100 · All sexes

Inclusion Criteria:

1. Over 18 years of age
2. Ejection fraction \<40%
3. Cardiogenic shock defined by clinical criteria (including any of: lactate \>2.5 mmol/L, systolic blood pressure \<90 mmHg, acute kidney or liver injury, or cardiac index \<2.1 on hemodynamic monitoring) plus the clinical requirement for at least one pressor, inotrope, or temporary mechanical circulatory support device (MCSD)

Exclusion Criteria:

1. History of LVAD or other durable ventricular assist device
2. An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke
3. Chronic enteric and parenteral nutrition support patients

Intubation or prior history of heart transplantation are not exclusion criteria if the inclusion criteria are otherwise met.

About the study

This study aims to determine, via skeletal muscle ultrasound (US), the extent, timing and relationship between skeletal muscle mass loss and outcomes after orthotropic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation amongst patients with cardiogenic shock. Advanced therapies such as OHT and VADs in the heart failure (HF) population may promote skeletal muscle mass and subsequent quality of life, but there is a lack of literature assessing muscle mass changes in HF patients before and after advanced therapies using US imaging. Therefore this observational study will provide further insight into the 1) changes in lean body mass during critical illness and 2) the feasibility of using bedside US to assess lean body mass in the inpatient setting.

What is being tested

• BodyMetrix Body Composition Ultrasound (diagnostic test)

Sponsor: Tufts Medical Center · Participants: 60 · Started: Feb 19, 2024

Contact the study team

• Amanda R Vest, MBBS · Phone: 617-636-8068

Official record on ClinicalTrials.gov — NCT06253104

Locations in the U.S.

Conditions

• Heart Failure
• Muscular Atrophy
• Cardiogenic Shock

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.